NCT00182013

Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.

Conditions

• Bipolar Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Risperidone	Open treatment with Risperidone
DRUG	Olanzapine	Open treatment with Olanzapine
DRUG	Quetiapine	Open treatment with Quetiapine

Timeline

• Start date: 2001-06-01
• Primary completion: 2004-02-01
• First posted: 2005-09-16
• Last updated: 2013-06-13